Senior Engineer - Process Engineering
Company: Disability Solutions
Location: Bloomington
Posted on: April 18, 2024
Job Description:
Senior Engineer - Process EngineeringCatalent is a global,
high-growth, public company and a leading partner for the
pharmaceutical industry in the development and manufacturing of new
treatments for patients worldwide. Your talents, ideas, and passion
are essential to our mission: to help people live better, healthier
lives.--Process Engineering focuses on developing processes to
minimize risks to the product. The role works with industry
experts/consultants to create design specifications, P&ID
drawings, general arrangement drawings, user requirements,
functional specifications, and automation control strategies.
Provides technical solutions to complex problems by relying upon
their experience and/or seeking recommendations from industry
experts.The Engineer will support ongoing activities by assisting
in troubleshooting mechanical problems, identifying improvements in
utilities to minimize interruptions (down time) and reduce energy
usage/cost, and supporting new and ongoing projects. This position
will further assist in the management and planning of project
budgets and schedules and provide contractor oversight.This
position will assist in identifying, tracking, forecasting, and
implementing capital expenditure projects by working with site
leadership and departmental end users to identify the correct
project parameters and utility requirements. The Engineer may
establish new Standard Operating Procedures (SOPs) and/or recommend
changes to current SOPs based on facility needs.This person will
work on complex facility-related problems requiring in-depth data
analysis to determine appropriate action. The Engineer is expected
to have extensive ongoing communication with employees and
cross-functional group managers/departments on facility-related
issues.This is a full-time, salary position. The shift is Monday-
Friday, days Catalent Pharma Solutions in Bloomington, Indiana is a
state-of-the-art, GMP manufacturing facility, providing one million
sq/ft of drug substance manufacturing, drug product manufacturing,
and related pharmaceutical services. This award-winning facility
helps customers accelerate biologic drug development programs and
bring better treatments to help patients live better healthier
lives.Catalent is committed to a Patient First culture through
excellence in quality and compliance and to the safety of every
patient, consumer, and Catalent employee.The Role:
- Support the multi-use facility, including HVAC systems and
bio-containment systems
- Support selection and installation of manufacturing
equipment
- Proactively and effectively partner with the facility
commissioning/validation team, including operational protocol
development, to implement compliance with FDA GMP requirements
- Draft SOPs for building operation, maintenance, and
calibration
- Identify improvements and efficiencies of facility preventative
maintenance
- Provide engineering guidance and execution on facilities and
equipment projects
- Perform hands-on activities as needed to help troubleshoot
facility problems and support facility staff
- Develop standard processes to evaluate future capital
projects
- Drive continuity and development of standards in Project
Engineering to ensure smooth and effective communication flow
between internal resources and customers, operational efficiency,
and equipment and personnel safety
- Create and maintain all aspects of equipment design files
- Guide the specification and selection of manufacturing/utility
equipment to support site facility/process needs
- Monitor, maintain, and repair existing production and
laboratory control and monitoring systems (PLC, sub-networks,
software, etc.)
- Apply and enhance existing automation validation programs for
the validation of new and existing production and laboratory
automated systems, including major capital projects and continuous
improvement of systems
- Review and approve changes to computerized automation
production and laboratory systems through the change control
program to assess impact on validated systems
- Assist in responding to customer/regulatory audit observations
and corrective actions as it pertains to automation system
validation
- Identify and implement improvement opportunities for
established production systemsThe Candidate:
- Bachelor's degree in Chemical/Mechanical/Electrical Engineering
or appropriate scientific discipline, required
- Master's degree, preferred
- PE / Registered Engineer in training, preferred
- OSHA/IOSH/NeBOSH Certification or equivalent, preferred
- 5+ years Project Engineering relevant experience
- 2+ years in a regulated industry (Life Sciences,
preferred)
- Must be able to read and understand English-written job
instructions and safety requirementsWhy you should join Catalent:
- Defined career path and annual performance review and feedback
process--
- Diverse, inclusive culture--
- 152 hours of PTO + 8 paid holidays
- Dynamic, fast-paced work environment
- Positive working environment focusing on continually improving
processes to remain innovative
- Potential for career growth on an expanding team within an
organization dedicated to preserving and bettering lives--
- Competitive salary with quarterly bonus potential--
- Community engagement and green initiatives--
- Generous 401K match--and Paid Time Off accrual--
- Medical, dental and vision benefits effective day one of
employment--
- Tuition Reimbursement--
- Wellness programsCatalent offers rewarding opportunities to
further your career!-- Join the global drug development and
delivery leader and help us bring over 7,000 life-saving and
life-enhancing products to patients around the world. Catalent is
an exciting and growing international company where employees work
directly with pharma, biopharma and consumer health companies of
all sizes to advance new medicines from early development to
clinical trials and to the market. Catalent produces more than 70
billion doses per year, and each one will be used by someone who is
counting on us. Join us in making a difference.--Catalent is
committed to the health and safety of its employees, visitors and
the customers and patients we serve. As a result of the global
pandemic, we have modified many of our recruitment and on-boarding
processes to maintain everyone's safety. The Human Resources teams
will communicate all necessary safety processes and procedures
throughout each stage.------personal initiative. dynamic pace.
meaningful work.Visit to explore career opportunities.Catalent is
an Equal Opportunity Employer, including disability and veterans.If
you require reasonable accommodation for any part of the
application or hiring process due to a disability, you may submit
your request by sending an email, and confirming your request for
an accommodation and include the job number, title and location to
. This option is reserved for individuals who require accommodation
due to a disability. Information received will be processed by a
U.S. Catalent employee and then routed to a local recruiter who
will provide assistance to ensure appropriate consideration in the
application or hiring process.--------Notice to Agency and Search
Firm Representatives: Catalent Pharma Solutions (Catalent) is not
accepting unsolicited resumes from agencies and/or search firms for
this job posting. Resumes submitted to any Catalent employee by a
third party agency and/or search firm without a valid written &
signed search agreement, will become the sole property of Catalent.
No fee will be paid if a candidate is hired for this position as a
result of an unsolicited agency or search firm referral. Thank
you.Important Security Notice to U.S. Job Seekers:Catalent NEVER
asks candidates to provide any type of payment, bank details,
photocopies of identification, social security number or other
highly sensitive personal information during the offer process, and
we NEVER do so via email or social media. If you receive any such
request, DO NOT respond- it is a fraudulent request. Please forward
such requests to spam@catalent.com for us to investigate with local
authorities.California Job Seekers can find our California Job
Applicant Notice .
Keywords: Disability Solutions, Louisville , Senior Engineer - Process Engineering, Engineering , Bloomington, Kentucky
Didn't find what you're looking for? Search again!
Loading more jobs...